BJ Rimel, MD
My son plays an online shipping game. He is a big fan of ships and, truthfully, shipwrecks as well. The game involves the player getting a product around the world with a certain number of tankers, tugboats, factories, and workers. Successful delivery means more money to buy more boats, expand factories, and pay workers more. He is a clever kid, so I asked him if he wins all the time. To my surprise, he said he has never won. When I asked him why, he said, “I can’t see what everyone else has.” His ability to successfully get supply to all his sites is inhibited by the lack of information about the other players’ statuses, how much they have, where their ships are, and what ports have already been served.
Recently, our SGO Cervical Cancer Taskforce was discussing our specific concerns for cervical cancer and the subject of drug shortages came up. This week, NBC news reported that there are critical shortages of cisplatin, methotrexate, 5-FU and Pluvictor and BCG. ASCO news announced on April 6 that the FDA-reported cisplatin shortage has “grown acutely in the last week or two.” The FDA reported that the supplier Accord/Intas released a supply during the week of April 6 and more was expected, but the shortage is, in fact, real. Some centers have no drugs at this time, and, for our cervical cancer patients, there is a profound difference between curative intent radiation and chemoradiation with cisplatin; the difference in PFS and OS is 39% (relative risk of death 0.61, 95% CI 0.41-0.81) (Rose et al NEJM 1999).
https://www.nejm.org/doi/full/10.1056/NEJM199904153401502
So, why is this shortage happening? There are several hypotheses, but my son’s insight about his shipping game is a major one. The lack of transparency in the pharmaceutical manufacturing, supply, and trade are serious problems for patients getting drugs that are past their patent. Please read further on this topic here.
There is no centralized data repository of manufacturers, regulators, and hospital/pharmacy systems that could identify a potential shortfall and correct it. Manufacturers can decide that a drug is not a “good business choice” and discontinue it because few people use it and they cannot get a good price for it. Manufacturers also do not share information about sources of raw ingredients, other essential materials (excipients, etc.), or distribution channels. Wealthier health systems can stockpile medications leaving other poorer systems without access. Regulatory bodies in different countries can’t and don’t share information about manufacturers they have inspected.
How can we, as gynecologic oncologists, respond to this shortage? We can publicly cite necessary changes in our drug and supply chain infrastructure to protect curative cancer therapies. We can also communicate with each other directly, as our Society is particularly connected; we are not just colleagues but friends. No one is doing this job for the money; we do this for our patients and for their families. If a patient cannot get the drug they need at one place, we can phone a friend and send the patient where there is supply. Just like when our specialty first began, gynecologic oncologists are the secret weapon our patients have against their cancer.
BJ Rimel, MD, is a Gynecologic Oncologist at Cedars-Sinai Medical Center in Los Angeles, CA.